- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519739
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
October 28, 2019 updated by: Abbott Medical Devices
Clinical Evaluation of Mediguide System in CRT Implants
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
- Currently participating in any other clinical study
- Have prosthetic valves
- Are pregnant or planning pregnancy in the next 1 month
- Are less than 18 years of age
- Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MediGuide Arm
|
MediGuide™ system will be used to guide CRT implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The performance of the MediGuide™ system during CRT implant
Time Frame: 1 month post CRT implant
|
Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.
|
1 month post CRT implant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 27, 2012
Study Record Updates
Last Update Posted (Actual)
October 30, 2019
Last Update Submitted That Met QC Criteria
October 28, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-11-043-EU-MG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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